Anxiety SensitivityGroup BEASTNCT05458362
Brief Enhanced Anxiety Sensitivity Treatment (Group)
A study testing Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST) in people with Anxiety Sensitivity and Anxiety, run by Ohio University at 1 site in United States.
Trial summary
One-third of the U.S. population experience anxiety disorders in their lifetime and only 25% of them seek treatment, reporting logistics and cost of treatment among the primary barriers. A potential way to prevent and treat multiple anxiety disorders is to target the risk factors that contribute to their etiology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Sensitivity, Anxiety
- What is being tested?
- Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elevated anxiety sensitivity symptoms (i.e., ASI-3 scores greater than or equal to 17),
- have access to a device smartphone with internet connection.
Who cannot join
- cardiovascular disease or stroke
- respiratory disorders (asthma, COPD, other),
- renal disease,
- epilepsy or other seizure disorder,
- and uncontrolled hypertension or migraines.
- current substance use disorder (severe),
Show all 10Show fewer
- uncontrolled manic symptoms,
- uncontrolled psychotic symptoms,
- suicidal ideation that requires hospitalization,
- if the participants endorse that English is not their first language in the screening questionnaire and demonstrate significant impairment in understanding the interviewer, they will be considered not proficient in English and will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Mobile App Augmentation to a Brief Anxiety Sensitivity Treatment
One-third of the U.S. population experience anxiety disorders in their lifetime and only 25% of them seek treatment, reporting logistics and cost of treatment among the primary barriers. A potential way to prevent and treat multiple anxiety disorders is to target the risk factors that contribute to their etiology. One such well-researched risk factor is anxiety sensitivity (AS), a fear of anxiety-related sensations. Given a need for affordable and accessible brief treatments, we and our colleagues have been iteratively developing Brief Enhanced Anxiety Sensitivity Treatment (BEAST), a one-session virtual treatment targeting AS. Older versions of BEAST include psychoeducation, interoceptive exposure (IE), and IE homework. Several studies showed that the previous versions of BEAST reduced AS and, through the reductions in AS, they also reduced anxiety. However, the effect sizes for the decrease in anxiety were modest. Efficacy and personalization may be improved using Ecological Momentary Intervention (EMI). EMI delivers brief interventions remotely in real-time and in natural settings. The goal of the current study is to test the efficacy of adding EMI to BEAST. Participants will be randomly assigned to EMI and control (no EMI) conditions. All participants will receive a virtual 1.5-hour-long intervention group session facilitated by a therapist. The EMI group will receive individualized intervention messages helping them to use new skills for two weeks after the session. After the two-week EMI period, all participants will complete post-treatment measures of AS and anxiety. A month later, they will complete a follow-up assessing AS and anxiety. The efficacy of the EMI component in reducing AS and anxiety will be tested using multilevel modeling. Improving the efficacy of BEAST, while keeping it brief, affordable, and accessible online, is an important step towards making it a treatment that may be used on a large scale.
Read the detailed description
There is a high need for prevention and treatment of anxiety disorders and for more accessible and affordable treatments. Targeting a risk factor for development and maintenance of multiple anxiety disorders may be an efficient way to prevent and treat anxiety. Anxiety sensitivity (AS)-the fear of anxiety sensations because of the belief that these sensations may lead to catastrophic outcomes-is a potent prevention and treatment target because it predicts development and maintenance of anxiety over time. Anxiety Sensitivity Amelioration Training (ASAT) is an ultra-brief, affordable treatment delivered virtually that targets AS. ASAT is a potent prevention and treatment protocol that reduces anxiety by reducing AS. However, the effect sizes were modest.
Adding Ecological Momentary Intervention (EMI) to the treatment could motivate the participants to apply skills they learned in treatment in a variety of real-life situations and to practice homework exercises. EMI delivers the intervention remotely in real-time and in natural settings, providing better learning through deeper processing. EMI alone is an effective treatment for anxiety and has been an efficacious enhancement to a 6-session treatment for generalized anxiety disorder. However, adding EMI to a 6-session panic disorder treatment did not improve the efficacy of the intervention. Because EMI can reduce anxiety as a stand-alone treatment and due to the inconclusive results about the efficacy of EMI as an added component, it is important to test the effect of adding EMI to the ASAT. We called the treatment including EMI the Brief Enhanced Anxiety Sensitivity Treatment (BEAST).
The goal of this study is to compare the efficacy of the BEAST with and without the EMI component. Interventions will be delivered to the adult community members and students in Athens, Ohio. Based on the power analysis, 75 adult participants will be recruited using email and online advertising. Based on methods used in the prior studies and the current design, inclusion criteria are elevated AS symptoms, access to a smartphone with internet connection. Exclusion criteria are heart disease, respiratory disorders, renal disease, seizure disorder, uncontrolled hypertension or migraines, current substance use disorder (severe), uncontrolled manic or psychotic symptoms, and suicidal ideation that requires hospitalization. All participants will receive a one-hour manualized group intervention educating about anxiety as an alarm system, the benign nature of anxiety sensations, myth-busting, and modifying biases about feared stimuli. The session will also include therapist-guided interoceptive exposure. Participants will be asked to do the exposure at home at least once a day for two weeks. For two weeks after the session, four times a day, the EMI group will receive prompts via the HIPAA-compliant EMI application (metricwire.com). The prompts will ask them about their current anxiety level. If they endorse elevated anxiety, they will be provided with a brief message reminding them about the coping skills covered during the session. They will also receive daily prompts to do exposures and enter the results in the app. The control group will not receive the EMI prompts and will be offered to complete EMI four weeks after the treatment. The intervention will be delivered by graduate students in a clinical Ph.D. program using Microsoft Teams, in groups of 4-6 participants.
AS and anxiety will be assessed using online questionnaires at baseline, at week two and week six after the delivery of the intervention session. Brief interview will be administered at baseline to assess the pathology listed in the exclusion criteria. Multilevel modeling will be used compare AS and anxiety between the groups at both follow-ups controlling for the baseline AS and anxiety. BEAST is an affordable intervention that can be used for prevention and treatment of anxiety and can be administered virtually. This is the first study testing the efficacy an added EMI component to a one-session-long anxiety intervention.
- Conditions
- Anxiety Sensitivity, Anxiety
- Being tested
- Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST), Control group Anxiety Sensitivity Treatment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST)Behavioural
Group BEAST consists of a 1.5-hour-long intervention session, followed by a 2-week-long EMI. During the intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety and stress), discuss popular misconceptions they may have about anxiety symptoms, and complete exposure exercises (e.g., practicing facing feared physical sensations such as trembling or elevated heart rate). Homework exposure exercises will be completed by all participants. They will receive phone app reminders about completing homework.
Only the EMI group will receive EMI prompts and intervention.
Control group Anxiety Sensitivity TreatmentBehavioural
Control group Anxiety Sensitivity Treatment consists of a 1.5-hour-long intervention session, followed by a 2-week-long EMI. During the intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety and stress), discuss popular misconceptions they may have about anxiety symptoms, and complete exposure exercises (e.g., practicing facing feared physical sensations such as trembling or elevated heart rate). Homework exposure exercises will be completed by all participants. They will receive phone app reminders about completing homework.
| Study group | Role | What they receive |
|---|---|---|
| EMI group | Experimental | For two weeks after the intervention session, participants will report on their anxiety level four times per day. When participants endorse elevated anxiety, they will receive a message relevant to their most stressful symptom at the moment reminding them of the topics covered in the intervention session.
As the efficacy of the EMI component is being tested, only the EMI group will receive EMI. Receives: Behavioral: Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST) |
| Control group | Active comparator | The control group will not receive EMI prompts and will be offered to complete EMI after the follow-up assessment. Receives: Behavioral: Control group Anxiety Sensitivity Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Sensitivity Inventory-3 (ASI-3; Taylor et al., 2007)
The ASI-3 is an 18-item self-report questionnaire of anxiety sensitivity measured on a 5-point Likert-like scale ranging from 0 (very little) to 4 (very much).
Measured: Screening, baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.
Change in PROMIS Anxiety scale - 8a
The PROMIS Anxiety scale measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always).
Measured: Baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.
Secondary outcomes (3)
Change multiple times a day - EMI anxiety questions (EMI group)
On every EMI measurement occasion, participants will be asked to report their level of anxiety using the question "How anxious are you?" on a scale ranging from 0 to 100. If they endorse elevated anxiety of 30 or above (Newman et al., 2014), they will be sent another question: What stressful symptoms are you experiencing? (a) Body sensations, (b) Mind and concentration, (c) Concerned about being judged for your anxiety symptoms. Next, they will be asked to choose a specific symptom from the dimension they have picked. Based on this symptom, they will be shown a message offering a CBT strategy to cope with the symptom and the distress effectively.
We will be sending the prompt 80% of the time when an elevated symptom level is reported (30-100 on a sliding scale) and provide intervention in 10% of cases when a low level of the symptom is reported (0-29 on a sliding scale).
Measured: 2 weeks of EMI - 4 times a day
Daily change - Short Scale Anxiety Sensitivity Index (all participants)
SSASI is a short version of the ASI-3 (Taylor et al., 2007). It is a 5-item questionnaire measuring AS on a 5-item Likert scale from 0 (very little) to 4 (very much). The SSASI has items corresponding to all three dimensions of AS: Physical concerns, cognitive concerns, and social concerns. This measure will be added to the first EMI prompt of the day. This will allow us to measure the change in the participants AS symptoms daily. The SSASI will be modified to assess symptoms during the past 24 hours.
Measured: 2 weeks of EMI - 1 time a day
Daily change - PROMIS Anxiety Short Form 8a Modified (all participants)
The PROMIS Anxiety Short Form will be modified to assess anxiety symptoms the participant has experienced yesterday as opposed to 7 past days. This measure will be added to the first EMI prompt of the day. This will allow us to measure the change in the participants anxiety symptoms daily.
Measured: 2 weeks of EMI - 1 time a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start9 Feb 2022
- Primary completion4 Jul 2022
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 1.5-hour intervention session will be completed by all participants. We will ask all participants to complete homework exposure exercises. They will receive phone app reminders about completing homework. Treatment group (EMI group): For two weeks after the session, four times a day, the EMI group will receive prompts via the HIPAA-compliant EMI application (metricwire.com). The prompts will ask them about their current anxiety level. If they endorse elevated anxiety, they will be provided with a brief message reminding them about the coping skills covered during the session. They will also receive daily prompts to do exposures and enter the results in the app. Control group: The control group will not receive EMI prompts and will be offered to complete EMI after the follow-up assessment.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Allan, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458362
- Sponsor's protocol ID
- Group_BEAST
- Acronym
- Group BEAST
- Status last verified
- Dec 2022
- First submitted
- 6 May 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allan NP, Capron DW, Lejuez CW, Reynolds EK, MacPherson L, Schmidt NB. Developmental trajectories of anxiety symptoms in early adolescence: the influence of anxiety sensitivity. J Abnorm Child Psychol. 2014 May;42(4):589-600. doi: 10.1007/s10802-013-9806-0.
PubMed 24062146Goetter EM, Frumkin MR, Palitz SA, Swee MB, Baker AW, Bui E, Simon NM. Barriers to mental health treatment among individuals with social anxiety disorder and generalized anxiety disorder. Psychol Serv. 2020 Feb;17(1):5-12. doi: 10.1037/ser0000254. Epub 2018 Aug 2.
PubMed 30070552Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.
PubMed 19646331Kenardy JA, Dow MG, Johnston DW, Newman MG, Thomson A, Taylor CB. A comparison of delivery methods of cognitive-behavioral therapy for panic disorder: an international multicenter trial. J Consult Clin Psychol. 2003 Dec;71(6):1068-75. doi: 10.1037/0022-006X.71.6.1068.
PubMed 14622082Keough ME, Schmidt NB. Refinement of a brief anxiety sensitivity reduction intervention. J Consult Clin Psychol. 2012 Oct;80(5):766-72. doi: 10.1037/a0027961. Epub 2012 Apr 2.
PubMed 22468909Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.
PubMed 19378696Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep;21(3):169-84. doi: 10.1002/mpr.1359. Epub 2012 Aug 1.
PubMed 22865617LaFreniere LS, Newman MG. A BRIEF ECOLOGICAL MOMENTARY INTERVENTION FOR GENERALIZED ANXIETY DISORDER: A RANDOMIZED CONTROLLED TRIAL OF THE WORRY OUTCOME JOURNAL. Depress Anxiety. 2016 Sep;33(9):829-39. doi: 10.1002/da.22507. Epub 2016 Apr 7.
PubMed 27062682Newman MG, Przeworski A, Consoli AJ, Taylor CB. A randomized controlled trial of ecological momentary intervention plus brief group therapy for generalized anxiety disorder. Psychotherapy (Chic). 2014 Jun;51(2):198-206. doi: 10.1037/a0032519. Epub 2013 Sep 23.
PubMed 24059730Schmidt NB, Capron DW, Raines AM, Allan NP. Randomized clinical trial evaluating the efficacy of a brief intervention targeting anxiety sensitivity cognitive concerns. J Consult Clin Psychol. 2014 Dec;82(6):1023-33. doi: 10.1037/a0036651. Epub 2014 May 12.
PubMed 24821096Schmidt NB, Eggleston AM, Woolaway-Bickel K, Fitzpatrick KK, Vasey MW, Richey JA. Anxiety Sensitivity Amelioration Training (ASAT): a longitudinal primary prevention program targeting cognitive vulnerability. J Anxiety Disord. 2007;21(3):302-19. doi: 10.1016/j.janxdis.2006.06.002. Epub 2006 Aug 4.
PubMed 16889931Schmidt NB, Mitchell MA, Richey JA. Anxiety sensitivity as an incremental predictor of later anxiety symptoms and syndromes. Compr Psychiatry. 2008 Jul-Aug;49(4):407-12. doi: 10.1016/j.comppsych.2007.12.004. Epub 2008 Mar 19.
PubMed 18555063Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):629-40. doi: 10.1001/archpsyc.62.6.629.
PubMed 15939840
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Mobile App Augmentation to a Brief Anxiety Sensitivity Treatment
- ClinicalTrials.gov ID
- NCT05458362
- Acronym / sponsor ID
- Group BEAST / Group_BEAST
- Conditions
- Anxiety Sensitivity, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One-third of the U.S. population experience anxiety disorders in their lifetime and only 25% of them seek treatment, reporting logistics and cost of treatment among the primary barriers. A potential way to prevent and treat multiple anxiety disorders is to target the risk factors that contribute to their etiology. One such well-researched risk factor is anxiety sensitivity (AS), a fear of anxiety-related sensations. Given a need for affordable and accessible brief treatments, we and our colleagues have been iteratively developing Brief Enhanced Anxiety Sensitivity Treatment (BEAST), a one-session virtual treatment targeting AS. Older versions of BEAST include psychoeducation, interoceptive exposure (IE), and IE homework. Several studies showed that the previous versions of BEAST reduced AS and, through the reductions in AS, they also reduced anxiety. However, the effect sizes for the decrease in anxiety were modest. Efficacy and personalization may be improved using Ecological Momentary Intervention (EMI). EMI delivers brief interventions remotely in real-time and in natural settings. The goal of the current study is to test the efficacy of adding EMI to BEAST. Participants will be randomly assigned to EMI and control (no EMI) conditions. All participants will receive a virtual 1.5-hour-long intervention group session facilitated by a therapist. The EMI group will receive individualized intervention messages helping them to use new skills for two weeks after the session. After the two-week EMI period, all participants will complete post-treatment measures of AS and anxiety. A month later, they will complete a follow-up assessing AS and anxiety. The efficacy of the EMI component in reducing AS and anxiety will be tested using multilevel modeling. Improving the efficacy of BEAST, while keeping it brief, affordable, and accessible online, is an important step towards making it a treatment that may be used on a large scale.
Detailed description
There is a high need for prevention and treatment of anxiety disorders and for more accessible and affordable treatments. Targeting a risk factor for development and maintenance of multiple anxiety disorders may be an efficient way to prevent and treat anxiety. Anxiety sensitivity (AS)-the fear of anxiety sensations because of the belief that these sensations may lead to catastrophic outcomes-is a potent prevention and treatment target because it predicts development and maintenance of anxiety over time. Anxiety Sensitivity Amelioration Training (ASAT) is an ultra-brief, affordable treatment delivered virtually that targets AS. ASAT is a potent prevention and treatment protocol that reduces anxiety by reducing AS. However, the effect sizes were modest.
Adding Ecological Momentary Intervention (EMI) to the treatment could motivate the participants to apply skills they learned in treatment in a variety of real-life situations and to practice homework exercises. EMI delivers the intervention remotely in real-time and in natural settings, providing better learning through deeper processing. EMI alone is an effective treatment for anxiety and has been an efficacious enhancement to a 6-session treatment for generalized anxiety disorder. However, adding EMI to a 6-session panic disorder treatment did not improve the efficacy of the intervention. Because EMI can reduce anxiety as a stand-alone treatment and due to the inconclusive results about the efficacy of EMI as an added component, it is important to test the effect of adding EMI to the ASAT. We called the treatment including EMI the Brief Enhanced Anxiety Sensitivity Treatment (BEAST).
The goal of this study is to compare the efficacy of the BEAST with and without the EMI component. Interventions will be delivered to the adult community members and students in Athens, Ohio. Based on the power analysis, 75 adult participants will be recruited using email and online advertising. Based on methods used in the prior studies and the current design, inclusion criteria are elevated AS symptoms, access to a smartphone with internet connection. Exclusion criteria are heart disease, respiratory disorders, renal disease, seizure disorder, uncontrolled hypertension or migraines, current substance use disorder (severe), uncontrolled manic or psychotic symptoms, and suicidal ideation that requires hospitalization. All participants will receive a one-hour manualized group intervention educating about anxiety as an alarm system, the benign nature of anxiety sensations, myth-busting, and modifying biases about feared stimuli. The session will also include therapist-guided interoceptive exposure. Participants will be asked to do the exposure at home at least once a day for two weeks. For two weeks after the session, four times a day, the EMI group will receive prompts via the HIPAA-compliant EMI application (metricwire.com). The prompts will ask them about their current anxiety level. If they endorse elevated anxiety, they will be provided with a brief message reminding them about the coping skills covered during the session. They will also receive daily prompts to do exposures and enter the results in the app. The control group will not receive the EMI prompts and will be offered to complete EMI four weeks after the treatment. The intervention will be delivered by graduate students in a clinical Ph.D. program using Microsoft Teams, in groups of 4-6 participants.
AS and anxiety will be assessed using online questionnaires at baseline, at week two and week six after the delivery of the intervention session. Brief interview will be administered at baseline to assess the pathology listed in the exclusion criteria. Multilevel modeling will be used compare AS and anxiety between the groups at both follow-ups controlling for the baseline AS and anxiety. BEAST is an affordable intervention that can be used for prevention and treatment of anxiety and can be administered virtually. This is the first study testing the efficacy an added EMI component to a one-session-long anxiety intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 1.5-hour intervention session will be completed by all participants. We will ask all participants to complete homework exposure exercises. They will receive phone app reminders about completing homework. Treatment group (EMI group): For two weeks after the session, four times a day, the EMI group will receive prompts via the HIPAA-compliant EMI application (metricwire.com). The prompts will ask them about their current anxiety level. If they endorse elevated anxiety, they will be provided with a brief message reminding them about the coping skills covered during the session. They will also receive daily prompts to do exposures and enter the results in the app. Control group: The control group will not receive EMI prompts and will be offered to complete EMI after the follow-up assessment.
| Arm | Type | Receives |
|---|---|---|
| EMI group | Experimental | Behavioral: Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST)For two weeks after the intervention session, participants will report on their anxiety level four times per day. When participants endorse elevated anxiety, they will receive a message relevant to their most stressful symptom at the moment reminding them of the topics covered in the intervention session. As the efficacy of the EMI component is being tested, only the EMI group will receive EMI. |
| Control group | Active comparator | Behavioral: Control group Anxiety Sensitivity TreatmentThe control group will not receive EMI prompts and will be offered to complete EMI after the follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elevated anxiety sensitivity symptoms (i.e., ASI-3 scores greater than or equal to 17),
- have access to a device smartphone with internet connection.
Key exclusion criteria (10 listed)
- cardiovascular disease or stroke
- respiratory disorders (asthma, COPD, other),
- renal disease,
- epilepsy or other seizure disorder,
- and uncontrolled hypertension or migraines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST)Group BEAST consists of a 1.5-hour-long intervention session, followed by a 2-week-long EMI. During the intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety and stress), discuss popular misconceptions they may have about anxiety symptoms, and complete exposure exercises (e.g., practicing facing feared physical sensations such as trembling or elevated heart rate). Homework exposure exercises will be completed by all participants. They will receive phone app reminders about completing homework. Only the EMI group will receive EMI prompts and intervention. | Behavioural | EMI group |
| Control group Anxiety Sensitivity TreatmentControl group Anxiety Sensitivity Treatment consists of a 1.5-hour-long intervention session, followed by a 2-week-long EMI. During the intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety and stress), discuss popular misconceptions they may have about anxiety symptoms, and complete exposure exercises (e.g., practicing facing feared physical sensations such as trembling or elevated heart rate). Homework exposure exercises will be completed by all participants. They will receive phone app reminders about completing homework. | Behavioural | Control group |
Primary outcome
Change in Anxiety Sensitivity Inventory-3 (ASI-3; Taylor et al., 2007)
Time frame: Screening, baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.
The ASI-3 is an 18-item self-report questionnaire of anxiety sensitivity measured on a 5-point Likert-like scale ranging from 0 (very little) to 4 (very much).
Change in PROMIS Anxiety scale - 8a
Time frame: Baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.
The PROMIS Anxiety scale measures anxiety broadly, including items to assess fear, anxious misery, hyperarousal, and somatic symptoms. Items are on a 5-point scale from 1 (Never) to 5 (Always).
3 secondary outcomes
Change multiple times a day - EMI anxiety questions (EMI group)
Time frame: 2 weeks of EMI - 4 times a day
Daily change - Short Scale Anxiety Sensitivity Index (all participants)
Time frame: 2 weeks of EMI - 1 time a day
Daily change - PROMIS Anxiety Short Form 8a Modified (all participants)
Time frame: 2 weeks of EMI - 1 time a day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Background: PubMed 24062146Allan NP, Capron DW, Lejuez CW, Reynolds EK, MacPherson L, Schmidt NB. Developmental trajectories of anxiety symptoms in early adolescence: the influence of anxiety sensitivity. J Abnorm Child Psychol. 2014 May;42(4):589-600. doi: 10.1007/s10802-013-9806-0.
- Background: PubMed 30070552Goetter EM, Frumkin MR, Palitz SA, Swee MB, Baker AW, Bui E, Simon NM. Barriers to mental health treatment among individuals with social anxiety disorder and generalized anxiety disorder. Psychol Serv. 2020 Feb;17(1):5-12. doi: 10.1037/ser0000254. Epub 2018 Aug 2.
- Background: PubMed 19646331Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1-39. doi: 10.1348/135910709X466063. Epub 2009 Jul 28.
- Background: PubMed 14622082Kenardy JA, Dow MG, Johnston DW, Newman MG, Thomson A, Taylor CB. A comparison of delivery methods of cognitive-behavioral therapy for panic disorder: an international multicenter trial. J Consult Clin Psychol. 2003 Dec;71(6):1068-75. doi: 10.1037/0022-006X.71.6.1068.
- Background: PubMed 22468909Keough ME, Schmidt NB. Refinement of a brief anxiety sensitivity reduction intervention. J Consult Clin Psychol. 2012 Oct;80(5):766-72. doi: 10.1037/a0027961. Epub 2012 Apr 2.
- Background: PubMed 19378696Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.
- Background: PubMed 22865617Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep;21(3):169-84. doi: 10.1002/mpr.1359. Epub 2012 Aug 1.
- Background: PubMed 27062682LaFreniere LS, Newman MG. A BRIEF ECOLOGICAL MOMENTARY INTERVENTION FOR GENERALIZED ANXIETY DISORDER: A RANDOMIZED CONTROLLED TRIAL OF THE WORRY OUTCOME JOURNAL. Depress Anxiety. 2016 Sep;33(9):829-39. doi: 10.1002/da.22507. Epub 2016 Apr 7.
- Background: PubMed 24059730Newman MG, Przeworski A, Consoli AJ, Taylor CB. A randomized controlled trial of ecological momentary intervention plus brief group therapy for generalized anxiety disorder. Psychotherapy (Chic). 2014 Jun;51(2):198-206. doi: 10.1037/a0032519. Epub 2013 Sep 23.
- Background: PubMed 24821096Schmidt NB, Capron DW, Raines AM, Allan NP. Randomized clinical trial evaluating the efficacy of a brief intervention targeting anxiety sensitivity cognitive concerns. J Consult Clin Psychol. 2014 Dec;82(6):1023-33. doi: 10.1037/a0036651. Epub 2014 May 12.
- Background: PubMed 16889931Schmidt NB, Eggleston AM, Woolaway-Bickel K, Fitzpatrick KK, Vasey MW, Richey JA. Anxiety Sensitivity Amelioration Training (ASAT): a longitudinal primary prevention program targeting cognitive vulnerability. J Anxiety Disord. 2007;21(3):302-19. doi: 10.1016/j.janxdis.2006.06.002. Epub 2006 Aug 4.
- Background: PubMed 18555063Schmidt NB, Mitchell MA, Richey JA. Anxiety sensitivity as an incremental predictor of later anxiety symptoms and syndromes. Compr Psychiatry. 2008 Jul-Aug;49(4):407-12. doi: 10.1016/j.comppsych.2007.12.004. Epub 2008 Mar 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Enhanced Anxiety Sensitivity Treatment (Group BEAST) in people with Anxiety Sensitivity and Anxiety, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Sensitivity Inventory-3 (ASI-3; Taylor et al., 2007) (time frame: Screening, baseline, post-treatment including EMI (2 weeks after the session), 1 month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458362, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.